ku1314520 一阶会员

这家伙还没有留下自我介绍
保密
关注: 7    |    粉丝: 34    |    积分: 368    |    威望: 0    |    访问: 2665
ku1314520 在 2023-09-17 22:42 回答了问题
Do we need the control groupin the animal experiment?
ku1314520: The animal experiment mainly provides evidence for thefinalization of product design, provides the evidence for the medicaldevice to enter the clinica...
ku1314520 在 2023-09-17 22:40 回答了问题
medical X-ray diagnostic equipment ( ClassIII)?
ku1314520: Please refer to the“Guidance for product registrationtechnical review of medical X-ray diagnostic equipment (Class Il ”Clinical parts usually include ...
ku1314520 在 2023-09-17 22:39 回答了问题
predicate medical device in clinicalevaluation?
ku1314520: Software difference may cause difference in productperformances,clinical functions and core algorithms. Accordingto the“Guidance for clinical evaluati...
ku1314520 在 2023-09-17 22:37 回答了问题
can we onlycompare the key performances?
ku1314520: Comparison with predicate medical device in clinicalevaluation for active medical device, what content to be comparedis relevant to the product featur...
ku1314520 在 2023-09-17 22:36 回答了问题
Under what circumstances do environmentatests need to be carried out on medical electricalequipment?
ku1314520: If the medical electrical equipment is expected to be used ina special environment (such as high temperature, high humidity orlow temperature), or if ...
ku1314520 在 2023-09-17 22:35 回答了问题
When submit Change of Permission Items foradding models, is it necessary for type testing?
ku1314520: First, it is necessary to identify whether the adding modelscan be regarded as the same registration unit with the originalmodels. If so, application ...
ku1314520 在 2023-09-17 22:34 回答了问题
can theelectrical safety and electromagnetic compatibility test beexempted?
ku1314520: The change of the shell structure and the overall sealingperformance of the equipment may lead to the change of theelectrical safety and electromagnet...
ku1314520 在 2023-09-17 22:32 回答了问题
Medical endoscopes have several models, how tochoose the typical model for type test?
ku1314520: Generally, the following factors should be taken into accountin the selection of typical endoscopes in one registration unit:For endoscopes with diffe...
ku1314520 在 2023-09-17 22:31 回答了问题
Do medical optical endoscope and laser fiberoptics need to be tested for EMC?
ku1314520: Both medical optical endoscope and laser fiber opticsbelongs to the applied part of medical electric equipment. They don'have main supply connection. ...
ku1314520 在 2023-09-17 22:30 回答了问题
Do wireless accessories of the active medicaldevices need to be tested during the EMC test?
ku1314520: Whether the active medical device accessories need to betested for EMC has nothing to do with the connection form of theproduct, which mainly depends ...
个人成就
获得 0 次赞同
被 34 人关注了
关注了 7 人